Talent.com
Diese Stelle ist in deinem Land nicht verfügbar.
Team Lead Global Regulatory Affairs Strategy (f / m / d)

Team Lead Global Regulatory Affairs Strategy (f / m / d)

AOP OrphanWien, DE
Vor 9 Stunden
Stellenbeschreibung

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a :

Team Lead Global Regulatory Affairs Strategy (f / m / d)

1190 Vienna Vollzeit Start : as of now

In this role, you will lead a regulatory affairs team and oversee strategy, submissions, and compliance for assigned products. Combining team leadership with hands-on regulatory expertise, you’ll ensure timely, high-quality submissions and effective lifecycle management across key therapeutic areas.

What Your Day To Day Will Look Like

  • Manage, support, and develop direct reports within the regulatory team, setting objectives and evaluating performance.
  • Act as regulatory lead for assigned products, coordinating submissions and ensuring compliance with EU and non-EU regulatory frameworks.
  • Supervise the preparation and maintenance of marketing authorization dossiers in collaboration with R&D and internal stakeholders.
  • Lead the lifecycle management of authorized products, including handling deficiency letters and change requests.
  • Drive regulatory planning and ensure alignment with internal and external timelines and expectations.
  • Maintain oversight of the regulatory quality management system (SOPs, work instructions, and departmental processes).
  • Coordinate with internal departments and external partners (e.g., RA consultants) on submission-related matters.
  • Oversee regulatory budget planning, invoice tracking, and consultancy fee processing.
  • Stay updated through continuous training and participation in external regulatory events.
  • Act as the administrator for Lorenz DocuBridge software for document and submission management.

Your  Qualifications and Experience

  • University degree in natural sciences or equivalent.
  • Minimum 5 years of regulatory experience with solid knowledge of EU regulatory frameworks and lifecycle management.
  • Proven ability or potential to lead a small team with strong organizational and decision-making skills.
  • Experience coordinating regulatory submissions and communicating with authorities.
  • Strong sense of responsibility, attention to detail, and ability to work independently.
  • Skilled in working cross-functionally and managing both internal and external stakeholders.
  • Excellent written and spoken English communication skills.

    • Our Offer

  • A position with personal responsibility and space for creativity
  • Open corporate culture with the opportunity to bring in your own ideas
  • Highly motivated, agile, and international team
  • Great opportunities for personal and professional development
  • Attractive work environment with excellent career opportunities and flat hierarchies
  • Competitive salary package plus bonus, various benefits
  • Gross annual salary for this function is a minimum of EUR 90.000.- based on full-time employment (38.5 hours / week). Any potential overpayment depends on professional experience and qualifications.

    • If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then :

    Jobalert für diese Suche erstellen

    Team Lead Global Regulatory Affairs Strategy (f/m/d) • Wien, DE